Kornimate/medical-research-clean huggingface dataset:
hbot in fibromyalgia

Conditions: Fibromyalgia; Chronic Pain

Summary: fibromyalgia (fm) is a chronic pain condition affecting several millions of canadians. although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. currently there is no cure for fm. pharmacological and non-pharmacological strategies are directed to control symptoms such as pain, fatigue, non-restorative sleep and depression. hyperbaric oxygen therapy (hbot) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere. physiological effect of hbot is based on a dramatic increase in the amount of dissolved oxygen carried by the blood which enables oxygenation of ischemic areas with compromised circulation. it also activates oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory response, induces brain neuroplasticity and possesses analgesic effect. while some interventions offer benefit for some patients, additional treatment alternatives are needed for patients with fm in whom currently available options are either ineffective or poorly tolerated. given its physiological effect, hbot could be considered as a potential therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system and controlling fm symptoms. the results from this study could therefore provide new information supporting the basic science underling the pathophysiology of this disease and stimulate novel therapies for patients suffering with fm.


Eligibility criteria:
inclusion criteria: * function improvement questionnaire (revised) score ≥ 60 during the baseline assessment. exclusion criteria: * women with positive pregnancy test or plans to become pregnant during the study period * claustrophobia * seizure disorder * active asthma * severe chronic obstructive pulmonary disease * previous thoracic surgery * history of pneumothorax * history of severe congestive heart failure with left ventricular ejection fraction \< 30% * unstable angina * chronic sinusitis * chronic or acute otitis media or major ear drum trauma * current treatment with bleomycin, cisplatin, doxorubicin and disulfiram * participation in another investigative drug or device trial currently or within the last 30 days

Keywords: hyperbaric oxygen treatment fibromyalgia global function sleep chronic pain depression anxiety
eswt in lateral epicondylitis: clinical,ultrasonographic evaluation

Conditions: Lateral Epicondylitis; Tennis Elbow

Summary: this study aimed to check and compare how well shock wave therapy works for tennis elbow, both in terms of symptoms and what we can see on ultrasound.

42 patients with tennis elbow were split into two groups by chance: one group received shock wave therapy (eswt), while the other received a fake treatment (sham-eswt) for comparison. both groups underwent wrist exercises, splint usage, and ice application. grip strength, pain levels, and how well they could move their wrist (functionality) were measured before, after, and one month post-treatment using tests. additionally, the thickness of a common extensor tendon (cet) was evaluated using ultrasound. the patient, the doctor checking the patient, and the doctor doing the ultrasound didn't know which group the patient was in.

Eligibility criteria:
inclusion criteria: * experiencing pain and tenderness in the lateral epicondyle while extending their wrist and fingers against resistance for at least 3 months exclusion criteria: * patients who are pregnant or have a coagulation disorder, cervical radiculopathy, peripheral neuropathy, peripheral vasculopathy in the upper extremity, complex regional pain syndrome, local infections, systemic inflammatory disease, fibromyalgia syndrome, arthritis (including rheumatoid arthritis, spondylarthritis, and crystal-induced arthropathies), malignancy, or those who have been treated with corticosteroids, prp, or autologous blood injection, as well as those who have received physical therapy agents, undergone upper-extremity surgical interventions, or have a history of direct trauma to the elbow or a history of fracture,

Keywords: extracorporeal shock wave therapy (eswt) sonographic assessment lateral epicondylitis
incidence of venous thromboembolic disease and portal vein thrombosis after hepatectomy. a cohort study.

Conditions: Pulmonary Embolism; Venous Thrombosis; Portal Thrombosis

Summary: observational. retrospective cohort.

venous thromboembolism (vte) is a disease that includes both deep vein thrombosis (dvt) and pulmonary embolism (pe). it is a common, potentially lethal disorder that can occur among postoperative patients. liver surgery implies a prothrombotic state, as a result of an alteration of the equilibrium between synthesis and use of pro and anti coagulant factors after a parenquimal resection. the use of antithrombotic prophylaxis following surgery is not standarized, and current practices vary depending on the attendant surgeon's particular experience or hospital's customs and habits. in published research, postoperative patients have been studied as a whole so far. there is little evidence regarding patients undergoing hepatectomy. furthermore, the use and need of extended prophylaxis remains unexplored in this group of patients. the objetives of the following study are: * to estimate the incidence of symptomatic venous thromboembolism (vte) \[deep vein thrombosis (dvt), pulmonary embolism (pe) and fatal pe\] in a third level center in patients undergoing any hepatectomy within 90 days after surgery. * to estimate the incidence of portal thrombosis (pt) in a third level center in patients undergoing any hepatectomy within 90 days after surgery. * to identify and describe factors associated to the development of vte in patients following hepatectomy. * to identify and describe factors associated to the development of pt in patients following hepatectomy. * to describe major bleedings or minor but clinically relevant bleedings during the period in which those patients received chemical thromboprophylaxis.

Eligibility criteria:
inclusion criteria: * older than 18 years old. * following hepatic surgery. exclusion criteria: * living donor * venous thromboembolism within 6 months previous to surgery.

Keywords: hepatectomy prophylaxis
pulmonary embolism - thrombus removal with catheter-directed therapy

Conditions: Pulmonary Embolism

Summary: pe-tract is an open-label, assessor-blinded, randomized trial, aiming to compare catheter-directed therapy (cdt) and anticoagulation (cdt group) with anticoagulation alone (no-cdt) in 500 patients with submassive pe, proximal pulmonary artery thrombus and right ventricular dilation.


Eligibility criteria:
inclusion criteria: 1. symptomatic pe diagnosed by contrast-enhanced ct angiography with involvement of a main or lobar pulmonary artery branch; and 2. right ventricular (rv) dilation as defined by the presence of an rv/left ventricular ratio \> 1 on ct angiography exclusion criteria: 1. age \< 18 years 2. systolic blood pressure \ 15 consecutive minutes or \> 40 mmhg drop from baseline, or vasopressor requirement for blood pressure support (i.e., massive pe), occurring within 1 hour prior to eligibility assessment. 3. symptom duration \> 14 days for the current pe episode 4. irreversible inr \> 3 5. irreversible thrombocytopenia (platelets \< 50,000/microliter) 6. creatinine \> 2.0 mg/dl 7. hemoglobin \< 7.0 g/dl 8. pregnancy (positive urine or blood pregnancy test (a pregnancy test must be obtained within 7 days prior to randomization in people of childbearing potential)) 9. allergy or hypersensitivity to recombinant tissue plasminogen activator (rt-pa), or iodinated contrast, except for mild-moderate contrast allergies for which steroid pre-medication can be used 10. life expectancy \< 1 year 11. chronic inability to independently walk prior to the current pe episode (e.g. wheelchair dependent, walker or cane dependent, paraplegic, and/or bed-bound) 12. allergy to heparin or history of heparin-induced thrombocytopenia (hit) 13. unable or unwilling to provide informed consent 14. major contraindication or unsuitability for all cdt methods available at the clinical center

Keywords: catheter-directed therapy (cdt)
propper prospective registry of outcomes with penile prosthesis

Conditions: Erectile Dysfunction; Impotence

Summary: the purpose of this observational registry is to collect and better understand "real-world" outcomes for men undergoing penile implant surgery to treat erectile dysfunction.

a prospective, multi-center, observational registry to be conducted at multiple sites throughout the united states and canada, to collect "real-world" penile prosthetic outcomes according to investigators' standard of care. using questionnaires as well as electronic data collection, investigating physicians will prospectively measure patient responses at regular intervals over a one- to five year period. the physician researchers have identified key metrics for the study including effectiveness, durability, complications, and patient satisfaction; quality of life will also be analyzed, being defined through several validated patient surveys.

Eligibility criteria:
inclusion criteria: men diagnosed with erectile dysfunction (ed) for whom an ams penile prosthesis is recommended by their physician are eligible for inclusion. potentially eligible men should also meet the following inclusion criteria for study enrollment: * willing and able to provide written informed consent prior to enrollment (if applicable). * willing to be seen or contacted by phone by the investigator and answer at least 2 questions related to satisfaction and device use 1 year following implantation of an ams penile prosthesis. exclusion criteria: - men who are deemed by their physician to be not suitable for a penile implant will be excluded.

Keywords: erectile dysfunction (ed) penile implant impotence penile prosthesis registry
nutrient pattern analysis in critically ill patients (nacho)

Conditions: Intensive Care Unit (ICU) Acquired Weakness (ICU - AW); Muscle Weakness

Summary: little is known about nutritional parameters that potentially influence the course of intensive-care unit acquired weakness (icu - aw). the investigators aim to elucidate the nutritional profiles in blood, urine and muscle in respective patients at risk.


Eligibility criteria:
inclusion criteria: * age ≥18 years * written informed consent obtained from the patient's legal representative and later from the patients (as soon as possible) * individuals diagnosed with severe head trauma or intracerebral hemorrhage ("central nervous system group") or with severe sepsis/ septic shock ("sepsis group") at any time from icu admission until day 5 (i.e. day of screening) * patient on the icu for ≥ 5 days ("icu long stayer") exclusion criteria: * language other than german or french * institutionalized individuals (e.g. prisoners, severe pre-existing mental incapacity) * patients with known pre-existing neurological or psychiatric disease that will make informed consent likely impossible * patients with known pregnancy or known to be lactating will not be included to the investigation. due to the observational/ diagnostical nature of the study, a pregnancy test will not be performed. * patients on extracorporeal membrane oxygenation (ecmo) * clinical signs of pre-existing malnutrition (body mass index \<18) * pre-existing evidence for history of anorexia or bulimia * parenteral nutrition received within last 5 days (for more than 12 hours) or evidence for parental nutrition needed within next 7 days * terminal disease (i.e. life expectancy \<14 days) * patients with active malignancy * patients on biologicals interfering with metabolism (e.g. infliximab) * patients on chronic steroid medication (i.e. prednisone equivalent dose \>10mg/day) * patients on neuromuscular blocking agents on a regular basis (i.e. on a repetitive basis within last 48 hours or evidence for need within next 7 days) * at screening (day 5): prescribed caloric intake substantially higher (i.e. \> 150% of caloric need of indirect calorimetry) than indirect calorimetric results (in intubated patients) or i.e. standard-of-care (25 kcal/kg body weight/day) * severe adipositas defined as bmi \>40 * known pre-existing allergy to standard enteral formulae * subject previously enrolled to an interventional trial that is not considered standard-of-care (e.g. investigation of new medication/drug or medical devices)
ketosis-prone diabetes mellitus (kpdm): metformin versus sitagliptin treatment

Conditions: Ketosis Prone Diabetes; Diabetes Ketoacidosis; Hyperglycemia

Summary: the study intends on enrolling 48 subjects with diabetes. diabetic subjects that no longer need insulin will be randomly placed (like the flip of a coin) on a diabetes pill called metformin, a diabetes pill called sitagliptin or a placebo pill (a pill without active medication). subjects on pills will be followed for 3½ years and undergo blood tests at specified intervals to assess their ability to make insulin. these studies will allow a better understanding of the factors that lead to high blood sugar in patients with ketosis-prone diabetes mellitus (kpdm) and direct the best diabetes treatment for this patient population. hypothesis: metformin therapy or sitagliptin therapy compared to placebo, will improve β-cell function, insulin sensitivity, and allow for a longer period of time prior to encountering an insulin-deficient relapse after discontinuation of insulin therapy.


Eligibility criteria:
inclusion criteria: 1. all newly diagnosed overweight/obese (bmi \>/=28 kg/m2) african-american patients with new-onset dka and/or severe hyperglycemia and without apparent precipitating cause will be considered for inclusion into the study. the diagnosis of dka will be established by standard criteria (blood glucose \> 250 mg/dl, ph \< 7.3, hco3 \< 18 mmol/l, increased anion gap). 2. the hyperglycemic group will include patients with an admission plasma glucose \> 400 mg/dl but without the presence of metabolic acidosis or ketosis. exclusion criteria: 1. significant medical or surgical illness, including but not limited to myocardial ischemia, congestive heart failure, chronic renal insufficiency, liver failure, and infectious processes; 2. recognized or suspected endocrine disorders associated with increased insulin resistance, such as hypercortisolism, acromegaly, or hyperthyroidism; 3. bleeding disorders, thrombocytopenia, or abnormalities in coagulation studies; 4. pregnancy, 5. have an allergy to any component of metformin or sitagliptin.
effectiveness of the ivivi torino ii, pulsed radio frequency device, on narcotic use, pain and quality of life following shoulder arthroscopic rotator cuff repair.

Conditions: Rotator Cuff Tear

Summary: to determine the effectiveness of non-thermal prf delivered with the ivivi torino ii on narcotic use, pain, and health-related quality of life following shoulder arthroscopic rotator cuff surgery comparing: active treatment versus placebo (sham).


Eligibility criteria:
inclusion criteria: * mri diagnosis of rotator cuff tear * persistent symptoms despite a minimum of 6 months of failed non-operative management * scheduled for primary or revision arthroscopic rotator cuff repair (with or without any of the following: debridement, subacromial decompression, distal clavicle resection, treatment of biceps tendon and /or glenoid labrum pathology, release of capsule). * age 40 to 80 years * able to read and complete english-language surveys * ability of the participant to comprehend the full nature and purpose of the study including possible risks and side effects * willingness and ability to comply with study product and methods exclusion criteria: * diagnosis of adhesive capsulitis requiring global capsular release, instability, fracture, or arthritis * any implanted metallic leads, wires, or systems (e.g. pacemaker, implantable cardioverter-defibrillator) * known narcotic allergy, hepatitis, nephritis, or gastrointestinal ulcer * chronic narcotic pain medication dependency * vulnerable populations including prisoners, pregnant women, nursing home residents, the investigator's students and employees, employees of sponsor, those unable to consent for themselves, uninsured subjects or others who could be subject coercion * worker's compensation claimant * medical condition, in the judgement of the patient's physician, which may interfere with the shoulder surgery or the effectiveness or safety of the study treatment * use of oral prednisone in the past 30 days * use of any investigational drug or participation in another research study within the past 30 days * self-reported diagnosis of autoimmune or inflammatory arthritis (e.g. rheumatoid arthritis, lupus, ets.)

Keywords: arthroscopic rotator cuff repair electromagnetic field treatment pulsed radio frequency treatment non-invasive non-thermal
nutritional status in children with ibd

Conditions: Inflammatory Bowel Diseases; Child

Summary: malnutrition and growth retardation are major extraintestinal presentations of inflammatory bowel disease (ibd) in childhood and are especially prevalent among those with crohn's disease. we aimed to evaluate nutritional status of children with ibd at the time of diagnosis.

data for this study will be derived from the web-based national registry for pediatric ibd. the children (age: ≤ 18 years) who diagnosed with ibd according to international criteria will be eligible for enrollment. data on demographic, clinical and laboratory characteristics at the time of diagnosis were extracted from the registry. all cases in the registry will be screened for eligibility criteria by principal investigator (senior gastroenterologist). the patients with other chronic disease known affect nutritional status will be excluded. the cases who had the missing major outcome variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis will be excluded from the analysis, if they had all of these outcome variables, they were included. the nutritional status of participants will be evaluated based on anthropometric parameters. the weight status will be assessed by weight-for-length in children \ +2.0, respectively. stunting (short stature) and tallness will be defined as length/height-for-age z score \ +2.0, respectively. children will be stratified into two age groups for analysis: \< 10 years of age and older. a p value of \<0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: 1. age: ≤ 18 years 2. diagnosis of ibd with clinical, laboratory, endoscopic and histopathologic findings 3. no other chronical diseases known affect nutritional status 4. no missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis exclusion criteria: 1. age: \>18 years old 2. another chronical disease known affect nutritional status 3. missing data in major variables including symptom duration, weight, height, disease activity, disease location and phenotype at the time of diagnosis

Keywords: i̇nflammatory bowel disease children nutritional status
home versus hospital care in glucose monitoring of gestational diabetes and mild gestational hyperglycemia

Conditions: Gestational Diabetes Mellitus; Pregestational Diabetes Mellitus; Mild Gestational Hyperglycemia

Summary: pregnancies complicated by diabetes and mild gestational hyperglycemia are associated with increased perinatal and maternal complications. the most serious maternal complication is the risk of developing type 2 diabetes after 10-12 years of the delivery. perinatal complications include fetal macrosomia with consequent increased risk of obstetrical trauma and hypoxia/asphyxia, high rates of cesarean section, respiratory distress syndrome, and metabolic disorders at birth. regardless of the diagnosis of diabetes and mild gestational hyperglycemia, the perinatal outcome is directly related to maternal metabolic control. for the tight control of blood glucose, pregnant women are treated as home care (outpatient) or hospital care. objective: to evaluate the cost-effectiveness and safety of home versus hospital care of gestational diabetes and mild gestational hyperglycemia.


Eligibility criteria:
inclusion criteria: * patients who were diagnosed with gestational, pre gestational diabetes mellitus or mild gestational hyperglycemia. patients should have one of the four criteria as following: * patients with positive screening for gdm presenting a ttg of 75 g and one of the values below: * fasting glucose ≥ 92; * 1h ≥ 180; or * 2h ≥ 153 will be considered gestational diabetes mellitus (gdm) and these patients will be enrolled to a run-in phase consisting of diet and exercise during 15 days. if the patients still present an abnormal glycemic profile instead of the previous treatment with diet and exercise they will be enrolled in the study and randomized to either home or hospital care; or * patients with pre gestational diabetes mellitus type 1 or 2; or * patients with positive screening for gdm and presenting normal ttg of 75 g and abnormal glycemic profile, fasting ≥ 85 mg k/l 10 h to 18h post prandial ≥ 130 mg k/ ( rudge et al,1990). * normal ttg and an abnormal glycemic profile will be considered as mild gestational hyperglycemia * patient provided written informed consent. exclusion criteria: * twin pregnancy diagnosed until the date of randomization or; * fetal malformation diagnosed until the date of randomization.
integrated telemonitoring and nurse support evaluation

Conditions: Chronic Heart Failure

Summary: the purpose of the study is to test a new medical device for optimizing treatment of heart failure and compare its effect on outcome of patients with a recent hospitalization for worsening heart failure

patients after an episode of acute heart failure have an increased risk of rehospitalisation and impaired prognosis for survival. neither a sole mobile nurse support nor a sole telemonitoring system has been able to provide consistent data on a beneficial influence on prognosis. furthermore, the influence of frequent measurements of nt-pro-bnp in a home setting of heart failure patients has not been investigated so far. this study will test a new medical device (software) for optimizing treatment of heart failure patients and evaluate its impact on outcome of these patients.

Eligibility criteria:
inclusion criteria: * acute systolic heart failure with admission for at least 4 consecutive days * treatment with an ace-inhibitor/angiotensin receptor blocker, beta-blocker, mineralocorticoid receptor antagonist according to current esc-guidelines * treatment with a loop diuretic * stable renal function (egfr according to mdrd of at least 30ml) * written informed consent * minimum age of 18 years exclusion criteria: * unstable coronary artery disease with revascularisation of any type within the last two months * planned revascularisation or operation for valvular heart disease within the next 6 months * planned heart transplantation * uncontrolled hypertension * active myocarditis * malignant disease with a life expectancy of less than 18 months * chronic use of high-dose nsaid or cox-2-inhibitors * psychiatric disorders that make it unlikely to understand the protocol * participation in an other randomized trial * inability to operate a smartphone

Keywords: telemonitoring